Status:
COMPLETED
Safety/Effectiveness of Adding Monthly Dexamethasone to Weekly Avonex for MS
Lead Sponsor:
Providence Multiple Sclerosis Center
Collaborating Sponsors:
Biogen
Conditions:
Relapsing-remitting Multiple Sclerosis
Clinically Isolated Syndrome
Eligibility:
All Genders
18-55 years
Brief Summary
The purpose of the study is to determine whether giving intravenous dexamethasone every 4 weeks during the first 12 months of weekly Avonex dosing will reduce the progression of functional impairment,...
Detailed Description
Beta Interferon-1a (Avonex)was approved by the FDA in 1996 to treat relapsing-remitting multiple sclerosis. Clinical trials have shown evidence in the reduction of relapses and progression of neurolog...
Eligibility Criteria
Inclusion
- male and female patients between the ages of 18-55 years inclusive
- have provided informed consent to be screened for the study
- have been diagnoses as having MS
- meet the McDonald diagnostic criteria for RRMS or CHAMPS criteria for CIS
- have an EDSS score of 0.0-3.5
- have had no immunomodulator or cytoxic agents and have had no steroids or other immunosuppressants within 30 days prior to Baseline Visit
- must have had a brain MRI scan demonstrating lesions consistent with MS on T2-weighted or FLAIR images
- subjects must be willing and able to participate in all aspects of the study, including use of study medications as prescribed, and screening and follow-up clinical and MRI assessments
Exclusion
- type I of type II diabetes
- uncontrolled hypertension (systolic \>160 or diastolic \>100 despite medication therapy)
- history of suicidal ideation
- history of psychosis
- history of alcoholism or other substance abuse
- clinically significant coronary artery disease
- history of hepatic failure and chronic renal failure
- history of cancer other than basal or squamous cell carcinoma of the skin
- pregnancy or unwillingness to use adequate precautions to prevent pregnancy during the duration of this study
- nursing mothers
- history of stroke, dementia, seizure disorder, peripheral neuropathy, Parkinsonism, myasthenia, myelopathy or other primary degenerative disease of the central or peripheral nervous system
- history of peptic ulcer disease
- history of intolerance to corticosteroids or allergy to albumin
- history of osteoporosis
- history of Lupus, Sjogrens syndrome, Lyme disease or syphilis
- abnormal laboratory results indicative of significant hepatic, renal, hematopoetic, or coagulation dysfunction
- the entity of any disease entity, which in the opinion of the investigators would potentially prevent the patient from successfully completing 2 years participation in this trial or confound the observations made during this trial
- prior use of Avonex, Betaseron, Rebif, mitoxantrone, cyclophosphamide, azothioprine, methotrexate, cladribine, cyclosporin, CellCept, IVIG, natalizumab, anti T-cell or anti B-cell antibodies, plasmapheresis or other systemic immunosuppressant or cancer chemotherapeutic agents
- unwillingness or inability to comply with all the requirements of the protocol
- known diagnosis of osteoporosis
Key Trial Info
Start Date :
December 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00232193
Start Date
December 1 2003
End Date
August 1 2010
Last Update
July 22 2011
Active Locations (1)
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1
Providence MS Center
Portland, Oregon, United States, 97225